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AquAdvantage Salmon Innovation in Aquaculture R.L. Stotish President & CEO AquaBounty Technologies

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AquAdvantage Salmon

Innovation in Aquaculture

R.L. Stotish President & CEO

AquaBounty Technologies

FARMED ATLANTIC SALMON

Global salmon production worth $10 billion Combined the world’s salmon farmers produce 2.1 million metric tons of salmon, from

just 0.00008 percent of the world’s oceans, says new report. IntraFish Media

ISFA Report 2015

US SALMON IMPORTS 2015 U.S. Atlantic salmon imports, value by selected sources (1,000 U.S. dollars)

Product, country code and name

2008 2009 2010 2011 2012 2013 2014 Jan-Feb 14 Jan-Feb 15

3370 Chile 771,973 487,745 292,885 563,398 748,492 1,080,485 1,332,251 228,557 209,798

1220 Canada 448,444 429,078 495,073 478,325 503,259 472,752 354,304 61,783 73,606

4039 Norway 54,029 243,579 399,592 222,054 137,535 201,523 294,531 39,216 57,749

4120 United Kingdom 66,096 108,719 112,849 113,566 88,916 109,640 133,504 23,513 14,632

4091 Faroe Islands 14,588 58,588 66,781 97,208 67,429 120,283 127,219 23,435 8,254

5700 China (Mainland) 29,394 32,142 32,249 27,629 40,902 58,016 54,409 18,427 3,081

4099 Denmark 694 6,328 13,146 4,818 18 13,415 15,367 4,401 189

Other countries 8,533 19,704 26,356 13,213 19,537 19,287 44,806 3,942 10,428

Total

1,393,750 1,385,884 1,438,931 1,520,211 1,606,088 2,075,400 2,356,392 403,274 377,738

Date run: 4/3/2015 10:56:37 AM

U.S. Atlantic salmon imports, volume by selected sources (1,000 pounds) Product, country code and name

2008 2009 2010 2011 2012 2013 2014 Jan-Feb 14 Jan-Feb 15

3370 Chile 212,759 128,229 61,416 120,387 206,177 239,618 279,004 45,620 47,229

1220 Canada 166,657 157,620 168,766 156,511 193,026 148,547 104,399 15,087 24,718

4039 Norway 14,402 60,213 80,643 41,557 31,782 40,591 57,657 7,389 13,389

4120 United Kingdom 23,376 37,253 34,312 34,970 29,727 27,594 34,060 5,424 3,943

4091 Faroe Islands 6,540 23,117 20,886 32,926 25,981 33,127 35,606 5,598 2,339

5700 China (Mainland) 13,530 14,290 14,447 9,631 12,379 17,785 17,046 5,961 1,009

4099 Denmark 173 1,458 3,007 895 7 2,358 2,590 761 23

Other countries 1,994 4,475 5,366 2,649 4,765 4,387 8,783 835 2,261

Total

439,430 426,655 388,842 399,526 503,844 514,006 539,144 86,676 94,912

Date run: 4/3/2015 10:56:31 AM

57%

15%

12%

52%

19%

11%

DANISH SALMON – DENMARK– 2,000 TONS

5

AquAdvantage Salmon

Gains in Growth – Smolts (AAS vs. Nontransgenics)

Growth Curves (smolts)

AquAdvantage®

salmonStandard salmon

0

100

200

300

400

500

600

0 50 100 150 200 250 300 350 400 450

Days (from first feeding)

Weig

ht

(g)

AAS Standard

8

Regulatory sequences from ocean pout AFP gene &

coding domain from chinook salmon GH-1 cDNA

Selection

Milt

Non-transgenic Progeny

Transgenic Founder Transgene DNA

Microinjection

Fertilized

Microinjected

Eggs

Promoter Terminator GH cDNA

TATA

TAG ATG

AATAA

// //

1989

1992

1994

1996

1998

2000

2002

Microinject

P 1

F 1

F 2

F 3

F 4

F 5

2004

2006

2008

F 6

F 7

F 8

2016 F12

AquAdvantage Salmon

9

COMMERCIAL PRODUCTION OPERATIONS

ApprovedGrow-Out

Harvest

AAS Broodstock

Confirm

Genotype

PCR

Induce

Triploid

y

FACS

Confirm

Triploidy

FXX

Non-Transgenic

Salmon Female

nMXX

XXX

XXX XXX

XXXXX

XX XX

XX

Homozygous

AquAdvantage NeoMale

Diploid Triploid

Non-Transgenic Broodstock

Processed Salmon

Production of Triploid, Monosex, Eyed-AAS Eggs

Fertilize

Milt

Sale

Plasmid Transgene

Integrated Transgene

Product Definition

Phenotype

Durability

Food Safety

Claims

Approval

Post-Approval

Environmental

Assessment

FDA FINDINGS RELEVANT TO COMPOSITION

• AAS meet the standard of identity for Atlantic salmon established by FDA’s Reference Fish Encyclopedia

• No biologically relevant differences were detected in the levels of the gene product, or any endogenous metabolite or substance found in physiological pathways that could be impacted by that hormone

• AAS contained the expected amounts of nutritionally important omega-3 and omega-6 fatty acids at the appropriate ratio for a fish source

• No biologically relevant differences were found in the allergenicity of edible products

• Found no biologically relevant difference between food from AAS and conventional Atlantic salmon

• Food from AquAdvantage Salmon is as safe to eat as food from other Atlantic salmon

• http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm201810.htm

VMAC Briefing Packet

September 20, 2010

VMAC Briefing Packet AquAdvantage Salmon - Page 24

Phenotypic Characterization c. General Observations

ABT conducted a controlled, blinded animal safety study at their PEI facility, which examined the

effect of the integrated AquAdvantage construct on the health of the GE animals. The study was a

careful and well-controlled assessment of the health of the fish and the following sections focus

primarily on the information provided in this study.

The general health and behavior of all of the fish was assessed by facility personnel and

independent veterinary professionals specializing in aquatic species. The study fish were observed

at the PEI facility at four separate time points following pre-enrollment qualification of the fish from

each study group. Assessments were made for feeding activity, behavior, posture, and

position in the water column, coloration, observation of any external lesions, morbidity,

mortality, and any other abnormal clinical signs. No health abnormalities were observed and

the fish were regarded as in good health and of normal behavior.

Conclusion: AquAdvantage Salmon show no general health or

behavioral abnormalities relative to comparator fish.

Phenotypic Characterization

In sum, the evidence collected and independently evaluated by

CVM shows that the creation, production, grow-out and human

consumption of AquAdvantage Salmon under the conditions

proposed in the Sponsor‘s NADA and described in this EA will

not result in significant adverse effects on the environment.

Environmental Assessment for AquAdvantage® Salmon New Animal Drug Application

Submitted by AquaBounty Technologies, Inc.

Environmental Assessment

ORIGINAL ARTICLE

Reproductive performance of alternative male phenotypes of growth hormone transgenic Atlantic salmon

(Salmo salar)

Darek T. R. Moreau,1 Corinne Conway2 and Ian A. Fleming1

1 Ocean Sciences Centre, Cognitive and Behavioural Ecology, Memorial University of Newfoundland, St John’s, Newfoundland, Canada

2 Ocean Sciences Centre, Memorial University of Newfoundland, St John’s, Newfoundland, Canada

Evolutionary Applications ISSN 1752-4571 (2011)

Transgenic salmon exhibit reduced breeding

efficiency (>10X) when compared to anadromous

“wild type” salmon in an artificial mesocosm

DAILY FEED INTAKE OF TG SALMON WAS 3 FOLD HIGHER

THAN NTG REGARDLESS OF PLOIDY AND DIET

Ganga et al, 2015

TGC OF TG SALMON WAS 3 FOLD HIGHER THAN NTG

REGARDLESS OF PLOIDY AND DIET

Ganga et al, 2015

FCR WAS SIGNIFICANTLY LOWER (20%) IN TG

THAN NTG REGARDLESS OF PLOIDY&DIET

0.69

0.92

0.68 0.72

0.99

0.72

0.85

0

0.2

0.4

0.6

0.8

1

1.2

TG NTG

2N FM 2N PP 3N FM 3N PP

0.87

a a a

bc

b b

c

FC

R (

g D

M f

ee

d/g

we

t w

eig

ht

ga

in)

Ganga et al 2015

0

5

10

15

20

25

30

35

40

45

50

FM PP FM PP

DIP TRIP

TG NTG N

RE

(%)

c c bc bc

b bc

a

bc

Higher Protein Retention Efficiencies in TG vs

NTG

Ganga et al, 2015

0

10

20

30

40

50

60

70

80

90

FM PP FM PP

DIP TRIP

TG NTG

LRE

(%)

d

d

c

c

b

c

a

bc

Higher Lipid Retention Efficiencies in TG

vs NTG

Ganga et al, 2015

New York

Oslo

Santiago

Miami

Series

1, C,

1.24

Series

1, N, 1.13

Series

1, A ,

0.05

AquAdvantage®

Salmon

Norwegian

Salmon

Chilean

Salmon

AquAdvantage® Salmon could reduce both the carbon footprint and cost of transportation

Carbon emissions (CO2-equivalent) per lb salmon transported*

*Calculation based on transporting salmon by truck and air freight from point to point at representative loading capacities, fuel efficiencies and distances. Salmon are transported approximately an

average of 300 miles to Oslo for air freight to New York and 640 miles to Santiago for air freight to Miami. 1 nautical mile (NM) = 1.15 miles.

Sea Cages

Lower Capital Cost

Regions with suitable coastline

Exposure to pathogens

Escape of fish

Predators, jellyfish, hazardous algal blooms

Use of medications, chemicals

Ecology of coastal waterways

Biosecurity issues, vandalism

Extreme weather events

Exposed working conditions

Operation (wellboats, etc.)

Transportation

AAS - RAS

Improved FCR/N2 retention

Greater biosecurity, zero escapes

Reduced/eliminated meds/chems

Siting close to consumers

Reduced transportation

Zero impact on biodiversity

Reduced environmental impact & carbon

footprint

Safe working conditions for employees

Higher Capital cost

Energy cost

Non-Exclusive Alternatives

Wild Caught

Management

Marketing

Distribution

Capacity

Stock Enhancement

Ranching

• Improve genetics

• Disease diagnosis, prevention and treatment

• Control of sex and fertility

• Improvement of growth, composition, and performance

• Traceability

Applications of Molecular Biology for Aquaculture

NADA 141-454

It’s really about food.